Case Study: Specialised Cleaning within the Pharmaceutical Sector

The importance of specialised GMP cleaning

For biopharmaceutical companies, high standards of hygiene and strict protocols are more than a matter of maintaining standards.

There have been internationally documented instances where lapses in pharmaceutical cleaning have led to patient sickness and death.

GMP regulations help manufacturers better recognise, investigate and take appropriate planned action to protect the consumer and marketplace from exposure to any potentially harmful ingredients or practices.

This involves stringent and wide-ranging cleaning regimes well above standard high-grade cleaning practices, requiring rigorous training and expertly designed protocols that are monitored through comprehensive documentation and frequent audits.

These include procedures and documentation that demonstrate compliance to the Therapeutic Goods Association (TGA), Food and Drug Administration (FDA) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) guide to manufacturing practices for medicinal products.

OCS has been certified GMP proficient in Australia. We also have the industry’s best trainers and operational field workers supporting our certified cleaning staff. This means many of the world’s leading pharmaceutical manufacturing operations have the confidence they need when working with us to provide their production cleaning services.

Strict protocols

OCS provides high-grade sanitation with strict adherence to protocols. This is critical for biopharmaceutical companies because most potential contaminants are microscopic, and a single microbe could cause an entire batch of drugs to be quarantined or discarded.

OCS team members follow stringent PPE guidelines wearing protective gloves, boots, eyewear, masks and head coverings. The team also uses cleaning agents, methods and products that are environment-appropriate, closely documenting all GMP activity.

Specialised Training

OCS teams are trained to work in highly sensitive environments according to Standard Operating Procedures (SOP). We also maintain an effective Corrective Action Preventive Action (CAPA) protocol which means our team members know how to prevent issues, and what to do if a problem arises.

Protecting Productivity

Through our customised solutions, OCS has been able to deliver many operational benefits to our biopharmaceutical customers, including:

• Protecting product yield
• Minimising lost product that may otherwise have needed to be discarded due to improper practice
• Reduction of waste of resources
• Protection of highly valuable pharmaceutical components
• Peace of mind, ensuring experiments and products are not compromised
• A safe environment, with the assurance that our partnership and commitment to expertise creates a safe environment for sensitive equipment
• Ultimately keeps operating costs down. Front-end prevention and care mean fewer losses and greater productivity.

Baxter Healthcare has worked in partnership with OCS Australia since 2010. Their team has taken special care to ensure the safety of our manufacturing equipment and facilities, enabling us to continue doing what we can to sustain and save lives through our products, equipment and services.

It’s no easy feat, with GMP cleaning requiring precise attention to detail, thorough training, comprehensive documentation, and adherence to a strict set of KPI’s. However, OCS go above and beyond the call of duty and we have absolute faith in what we do for this reason.